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Unredacted complaint reveals fentanyl manufacture Teva/Cephalon’s illegal marketing strategies

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~ Newly unsealed information shows for the first time the extent to which Teva/Cephalon lied about the uses and risks of their fentanyl drugs to boost sales ~

RICHMOND (February 10, 2020) – Newly unsealed information shows for the first time the extent to which Teva Pharmaceuticals, USA, Inc. and its predecessor Cephalon Inc. lied about the uses and risks of their fentanyl drugs to boost sales. The scale of Teva and Cephalon’s lies and deception was revealed in a newly unredacted Complaint in Attorney General Mark Herring’s lawsuit against the companies for their role in creating and perpetuating the opioid crisis through their unlawful, decades-long campaign to boost sales and deceive the public about these drugs. The unredacted Complaint shows how the companies took opioids the FDA had only approved for treating cancer patients’ pain and aggressively marketed them for a wide variety of prohibited off-label uses and encouraged non-cancer treating doctors, a third of whom were primary care physicians, to misprescribe these powerful drugs; discloses the FDA’s previously unknown stern warnings about the drugs, which the companies subsequently ignored; and shows how the companies manipulated clinical trial data to hide what they knew about their drugs’ addiction and overdose risks and how they exaggerated the drugs’ overall efficacy and benefits.

“Teva and Cephalon blatantly lied about the usage, the efficacy, and the risks of their extremely dangerous and addictive drugs in order to make billions of dollars in profit,” said Attorney General Herring. “Families in Virginia and around the country have been devastated by the ongoing opioid epidemic, which has its roots in the boardrooms and marketing departments of companies like Teva and Cephalon. This unredacted Complaint reveals how these opioid manufacturers had absolutely no problem with putting human lives at risk in order to make as much money as they could. I will not stop until pharmaceutical companies are held accountable and shoulder the financial burden for their role in creating and prolonging the opioid crisis.”

Since 2007, fatal fentanyl overdoses in Virginia have risen by nearly 1,600%, from just 48 in 2007 to more than 800 in 2018. In the same period, nearly 10,000 Virginians have died of a heroin or opioid overdose, including 5,700 from a prescription overdose, and nearly 3,500 from a fentanyl overdose, all while Teva/Cephalon made huge sums of money from its fentanyl drugs.

In October 2019, Attorney General Herring filed suit against opioid manufacturer Teva/Cephalon for engaging in what he alleges was an unlawful, complex, decades-long campaign to boost sales of fentanyl – the most potent narcotic currently approved for human use – by marketing its rapid acting fentanyl drugs for unapproved and unsafe uses, and by knowingly and intentionally downplaying the risks of its drugs while overselling the benefits.

Unlawfully Marketing and Promoting Cancer Pain Drugs for Non-Cancer Related Conditions
In 2008, Cephalon settled federal criminal charges and state civil charges for illegally marketing Actiq, a potent rapid-release form of fentanyl, which was administered via a raspberry-flavored fentanyl lollipop. Attorney General Herring’s unredacted Complaint reveals the involvement of Cephalon’s top managers in targeting and encouraging doctors to prescribe Actiq for a wide range of unapproved symptoms and issues, including “acute pain, premedication for procedures, post-surgical pain, kidney stones, tooth extractions, migraine pain, back pain, neuropathic pain, headache pain, arthritis, or fibromyalgia.”

The unredacted Complaint shows how these managers participated in conferences at high-end resorts, where they ostensibly “educated” high prescribers of other opioids about the benefits of Actiq for uses forbidden by the FDA using “educational” materials that they never submitted to the FDA. The unredacted Complaint shows how the conferences persuaded providers to go back to their home states, including Virginia, and use Actiq for unsafe and unapproved uses, all while Cephalon was telling the FDA it was discouraging the uses.

One email from a Cephalon agent to Andy Pyfer, Cephalon’s brand manager for Actiq, captures the company’s sales goals efforts at the time, summarizing a well-attended conference at a five-star San Diego resort by saying: “It was a great meeting. I think we definitely sold some Actiq.”

The unredacted Complaint also reveals for the first time the scope of Cephalon’s illegal sales practices at this time. It shows Cephalon aggressively targeted non-cancer prescribers and doctors with sales and promotional visits, including doctors specializing in “primary care, family medicine, physical medicine, and neurology,” even though the drugs were only FDA approved to treat cancer patients. Below is a breakdown of Cephalon’s sales calls in the first seven months of 2004:

The unredacted Complaint also reveals Cephalon’s “ride ‘em up ride ‘em down policy,” which encouraged salespeople to repeatedly target high prescribers up until the point authorities stepped in and stopped the prescriber. As the Complaint explains: “as a high-performing Florida salesperson put it about a high prescribing doctor…‘i[f] I knew that this physician was in town practicing medicine, I would’ve been in there three times a week pushing him to write more Actiq’”. Cephalon even “affirmatively told salespeople not to report or flag doctors who salespeople knew were prescribing Fentora off-label for the wrong conditions”.

Cephalon Ignored FDA Warnings
The unredacted Complaint reveals a previously unknown series of meetings between the FDA and Cephalon in 2004, in which top FDA officials warned Cephalon that the use of Actiq by non-cancer patients was “staggering…the Agency is very concerned that the situation that occurred with Oxycontin may happen again.” The FDA told Cephalon its sales practices were creating a “significant public health” problem, by providing non-cancer patients with a product so powerful it put them at risk of an immediate overdose.

The unredacted Complaint also reveals that Cephalon did not substantially change its practices with the introduction of Actiq’s successor Fentora, in 2006, a rapid-release fentanyl tablet. The company kept targeting providers who were prescribing Fentora for back pain, and other non-cancer conditions, and it kept turning a blind eye to the resulting problems.

Below is an egregious example of a company-approved response to a Q&A produced for their salespeople:

Knowingly Downplaying Risks of Abuse and Overdose While Overselling Benefits and Efficacy
The unredacted Complaint discloses clinical trial data showing that Cephalon and then Teva, which acquired Cephalon in 2011, knew Actiq and Fentora were widely abused and misused by clinical trial patients and knew the drugs were showing potentially alarming diminution in pain relief the longer the patients used them.

The unredacted Complaint reveals that data from clinical trials of Fentora showed that the drug “increased the risk of addiction while bringing fleeting and diminishing relief” and that “patients taking Actiq or Fentora for months or longer exposed themselves to extremely high risks and diminishing pain relief.” According to the unredacted Complaint, in one 18 month clinical trial patients had a:
• 31% increase in pain episodes per day, from 3.5 to 4.6 episodes/day;
• Took 26% more Fentora tablets per day, from 3.5 to 4.4 tablets/day; and
• Had a 42% increase in their average daily Fentora dosage, from 2,162 mcg/day to 3,088 mcg/day.

The companies ghostwrote publications in prominent academic journals, like Cancer, that deliberately misled prescribers and patients about these potential declines in the opioids’ pain relieving properties over time. As the unredacted Complaint notes of the Cancer publication about a long-term study of Fentora use by cancer patients, “the actual study data…suggested the opposite of what Cephalon claimed: that the patients who were in study for 12 months or more actually experienced a decline in analgesic efficacy, suggesting an increase in incremental tolerance to Fentora because they were taking more and more doses per day of Fentora and other opioids.” The unredacted Complaint shows that Teva made efficacy claims a “key pillar” of its marketing campaigns for Fentora from 2008 to the present, all while relying on misleading data.

Additionally, the companies were well aware of, but largely did not disclose, alarming clinical trial data about misuse, abuse, and addiction involving Fentora. The unredacted Complaint details how clinical trial patients in long-term cancer and non-cancer trials, none of whom had a history of substance abuse, started exhibiting alarming drug seeking behaviors, what the companies called “aberrant drug related behavior.”

For example, in one non-cancer long-term clinical trial there were frequent incidents of abuse and misuse:
• 11 patients overdosed;
• One patient’s husband overdosed;
• 35 patients reported their Fentora stolen;
• Dozens of patients dropped out of the trial without accounting for the 100-plus Fentora tablets they had been given; and
• Five study centers reported Fentora stolen from supposedly secured lockers.

The company claimed in limited disclosures to regulators like the FDA and its European Union counterpart, that the rates of aberrant drug related behavior in study patients were around 17%. Both the FDA and the EU thought this was alarming, and Cephalon’s internal discussions showed that medical staff believed this 17% rate could rise to “more than 41%” if patients took Fentora and other opioids for a year or more.

The unredacted Complaint also alleges that in marketing materials and publications disseminated to healthcare providers, academics, and the public, Teva and Cephalon knowingly omitted this data, failing to list these serious cases of misuse and abuse in its tables of adverse events, all while claiming its products were “generally safe” and “well tolerated.”

Attorney General Herring’s Work to Address the Opioid Crisis
As part of his ongoing efforts to hold pharmaceutical companies accountable for their role in creating and prolonging the opioid crisis, Attorney General Herring has also filed suit against Purdue Pharma and members of the Sackler Family, the owners of Purdue, alleging decades of illegal conduct designed to enrich the company and family by selling the most opioids possible. In his suit against the Sackler family, filed in September 2019, Attorney General Herring also alleges that the family fraudulently extracted billions of dollars from the company in an effort to put the money beyond the reach of investigators and those suing the company.

Attorney General Herring also continues to participate in a bipartisan, multistate effort to investigate and hold opioid manufacturers and distributors accountable for their roles in the opioid crisis.

The heroin and prescription opioid epidemic has been a top priority for Attorney General Herring. He and his team continue to attack the problem with a multifaceted approach that includes enforcement, education, prevention, and legislation to encourage reporting of overdoses in progress, expand the availability of naloxone, and expand access to the Prescription Monitoring Program. He has supported federal efforts to improve the availability of treatment and recovery resources and made prescription drug disposal kits available across the Commonwealth.

Download the unredacted complaint here.

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Governor Northam COVID-19 update briefing – August 5, 2020; rapid testing, Tropical Storm Isaias, restrictions in Hampton Roads area

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Governor Northam joins the Virginia Emergency Support Team to share the latest updates on the COVID-19 response. Here are the highlights:

  • COVID-Wise app to send alerts to those who have been in close contact with someone who has tested positive for COVID-19. The app is free, and voluntary, to download and use.
  • Joining 7 states to expand the use of rapid antigen testing.
  • Feds to continue to fund the majority of the National Guard’s presence in Virginia in response to both COVID-19 and tropical storms such as Isaias.
  • Increased restrictions remain in place in the Hampton Roads area.
  • Case counts have begun to slowly rise throughout most of Virginia, with a sharp rise in the Eastern Region. Seeing about 1,000 new cases per day, which is similar to the number of new cases per day at the peak. Averaging, statewide, between 15,000 and 20,000 tests per day. Statewide percent positivity is 7.2%.
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Supreme Court of Virginia denies appeals by Goodwin and Ramos for their role in the beating of Deandre Harris during Unite the Right Rally

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Attorney General Mark R. Herring and his team have again successfully defended the convictions of two men who were convicted of malicious wounding for their roles in the beating of Deandre Harris in a Charlottesville parking garage during the August 2017 “Unite the Right” rally. The Supreme Court of Virginia denied Jacob Scott Goodwin’s petition for appeal today and denied Alex Michael Ramos’ petition for appeal in early May.

“The violence, mayhem, injury, and death caused at the hands of the racists and white supremacists who descended on Charlottesville for the Unite the Right rally can never be forgotten, but we can make sure that the individuals who broke the law or incited violence are brought to justice,” said Attorney General Herring. “My team and I will do everything in our power to combat this white supremacist violence that we continue to see in the Commonwealth, and I will not hesitate to hold these racists and white supremacists accountable when they act on their hate.”

In each of the opinions denying the appeals, the Supreme Court of Virginia said, “Upon review of the record in this case and consideration of the argument submitted in support of the granting of an appeal, the Court refuses the petition for appeal.”

Goodwin was sentenced to serve eight years in prison and Ramos was sentenced to serve six years for their roles in the beating of Deandre Harris.

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Virginia State Police urging travel safety during tropical storm

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As the Virginia State Police prepares for Tropical Storm Isaias, Virginians are encouraged to get ready and plan ahead, too. Forecasts are currently calling for the eastern and central regions of the Commonwealth to be significantly impacted by heavy rains and strong winds.

Virginia State Police have all available troopers and supervisors working through the night and Tuesday as the storm makes its way across the Commonwealth. To prevent unnecessary traffic crashes from occurring on Virginia’s highways during the storm, state police advises residents to postpone travel plans and avoid driving, when possible.

If having to travel during the storm, drivers are reminded to do the following:

  • Slow your speed. Though state police works closely with the Virginia Department of Transportation (VDOT) to identify problem areas on Virginia’s highways during a storm, drivers still must drive for conditions. Slowing your speed gives you more time to safely react and avoid a crash, downed trees and/or debris in the roadway. Drive your vehicle based on your ability to properly maintain control of your vehicle.
  • Turn Around. Don’t Drown. Never drive through standing water. What looks like a puddle can be deep and swift-moving water. Turn around and find another, safer route to your destination.
  • Don’t tailgate. You need increased stopping distance on wet road surfaces. Give yourself more space between vehicles traveling ahead of you in order to avoid rear end collisions.
  • Use headlights. Increasing your visibility helps you to avoid standing water and/or flooding. Headlights also help other drivers see you better, especially in a downpour when visibility is limited.
  • Buckle Up. Most crashes that occur during inclement weather are caused by vehicles sliding off the road or other vehicles. Wearing your seat belt protects you from being thrown around the inside of your vehicle and suffering serious injury in a crash.
  • Put down your phone. Having to drive in heavy rain requires a driver’s full, uninterrupted attention. Do not text and drive or shoot video of the bad conditions while driving, as these actions put you, your passengers and other vehicles at extreme risk of a crash and/or injury.
  • Check Your Vehicle. Make sure your vehicle is in good working order for the conditions. Fill up the tank in advance. Check windshield wipers, tire tread, battery life, etc.

For the latest in road conditions and updates, please call 511 on a cell phone, download the App or go online to the VDOT Virginia Traffic Information Website at www.511virginia.org.

Virginians are advised to only call 911 or #77 on a cell phone in case of emergency. It is essential to keep emergency dispatch lines open for those in serious need of police, fire or medical response.

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Governor Northam declares State of Emergency in advance of Hurricane Isaias

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Governor Ralph Northam today declared a state of emergency in advance of Hurricane Isaias, which is expected to impact parts of coastal Virginia starting on Monday, August 3, 2020.

“Hurricane Isaias is a serious storm, and current predictions indicate that it may impact parts of Virginia as early as this weekend,” said Governor Northam. “This state of emergency will ensure localities and communities have the assistance they need to protect the safety of Virginians, particularly as we continue to deal with the COVID-19 crisis. I encourage Virginians to take all necessary precautions, monitor local weather forecasts, and stay alert.”

A state of emergency allows the Commonwealth to mobilize resources and equipment needed for response and recovery efforts. While the track of Hurricane Isaias is still uncertain, it appears increasingly likely that Virginia could see impacts and therefore must prepare for the possibility of flooding, high winds, and potential storm surge that could come along with a tropical storm or hurricane.

Virginians are encouraged to consult the Virginia Hurricane Evacuation Guide During the COVID-19 Pandemic, which outlines preparedness, response, and recovery actions designed to reduce the risk of transmission of COVID-19 and protect public health.

The Virginia Emergency Support Team (VEST) is actively monitoring the situation and coordinating resources and information to prepare for this storm. The Virginia Emergency Operations Center (VEOC) will coordinate preparedness efforts with local, state, and federal officials.

The full text of Executive Order Sixty-Nine is available here.

Recommendations for Virginians

• Know your zone. Evacuation may become necessary depending on the track and severity of the storm. Review Virginia’s evacuation zones at KnowYourZoneVA.org. It is important to note that the zone colors have been updated for 2020. Users can enter their physical address in the search bar of the website to view and confirm their designated evacuation zone. If the internet or computer access is not available, call 2-1-1 to learn your zone. Residents not residing in a pre-identified evacuation zone should listen to evacuation orders from local and state emergency agencies to determine if and when to evacuate.

• Make a plan. Virginians residing in eastern and coastal Virginia should consult the Virginia Hurricane Evacuation Guide During the COVID-19 Pandemic, which outlines ways to prepare for both weather and pandemic-related risks. Additional planning resources are available at ready.gov/plan.

• Prepare an emergency kit. For a list of recommended emergency supplies to sustain your household before, during, and after the storm visit VAemergency.gov/emergency-kit. Given the ongoing COVID-19 crisis, emergency kits should include face coverings and sanitization supplies.

• Stay informed. Virginians should follow the Virginia Department of Emergency Management on Twitter and Facebook for preparedness updates and their local National Weather Service office for the latest weather forecast, advisories, watches, or warnings. Download the FEMA app on your smartphone to receive mobile alerts from the National Weather Service. Power outages are always a concern during weather events—make sure you have a battery-operated radio available so you can still receive life-saving alerts.

For more information about preparing your business, your family, and your property against hurricane threats visit VAemergency.gov/hurricanes and ready.gov/hurricanes. Additional information about preparing for hurricanes during the COVID-19 pandemic can be found on the Centers for Disease Control and Prevention website.

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AG Herring again defends Virginia’s COVID safety measures

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Attorney General Mark R. Herring has again successfully defended Virginia’s COVID safety measures against legal challenge, making it at least the 13th decision Attorney General Herring and his team have won in defense of the Commonwealth’s COVID mitigation efforts that were put in place to prevent the spread of the virus and keep Virginians and their families and communities safe and healthy.

“Science has shown us that Virginia’s COVID mitigation efforts are proven effective in preventing further spread of the virus and keeping Virginians safe,” said Attorney General Herring. “As we continue to see a surge of cases around the country, including certain areas of Virginia, we know that we must continue to adhere to these critical safety measures to keep Virginians healthy. I am pleased we were once again able to successfully defend these important COVID mitigation measures, and I am really proud of the hard work my team has done to keep their fellow Virginians safe during these unprecedented times.”

The Plaintiff, in this case, William G. Dillon, Jr., who owns the Abbey Road restaurant in Virginia Beach, filed suit challenging the Governor’s executive orders that were passed to keep Virginians safe and healthy and prevent further spread of the deadly coronavirus. The Plaintiff sought a preliminary injunction that would allow him to have more patrons in his restaurant. Judge David W. Lannetti of the Norfolk Circuit Court denied the request for a preliminary injunction, as well as the plaintiff’s petition for writ of mandamus after finding that “Plaintiffs failed to prove that they will suffer irreparable injury without the requested temporary injunction, that the requested relief is in the public interest, and that the equities tip in their favor.” Additionally, Judge Lannetti acknowledges that the COVID-19 situation is ever-evolving, but he makes the point that “Courts…resolve legal – as opposed to social or political – questions; the other branches of government establish and enforce statutes and policies.”

This is the thirteenth decision Attorney General Herring and his team has won in defense of Virginia’s COVID mitigation measures, including two cases that explicitly challenged Virginia’s mask requirement, in addition to winning court cases to protect the vote during the COVID pandemic.

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Governor Northam COVID-19 update briefing – July 28, 2020; Hampton Roads area, CARES Act funds, going back to school

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Governor Northam joins the Virginia Emergency Support Team to share the latest updates on the COVID-19 response. Here are the highlights:

  • 4 out of 5 Virginia health regions are stable
  • Hampton Roads area need attention
  • continue to do the right things
  • wear masks
  • stay at home
  • social distancing
  • checking in on your neighbors
  • vaccines being fast-tracked
  • the nursing home situation turned around
  • testing up to 20,000 people per day
  • new executive order for Hampton Roads area
  • CARES Act funds will be distributed
  • working on quick-turnaround tests for COVID-19
  • “recipe for disaster” if students go back to school without numbers down
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